Bio-Pharma & MedTech Services
GMP and Regulatory Consultancy services specifically tailored for the Bio-Pharma and MedTech industries. We understand interdepartmental dynamics more deeply than standard consulting practices.
Our Service Offerings
Specialized consultancy services for Biologics, Medical Devices, In-Vitro Diagnostics (IVDs), and Software as a Medical Device (SaMD)
Startup Support
Comprehensive support services to help bio-pharma and medtech startups navigate quality, regulatory, and funding challenges.
- Staff Augmentation for Quality & Regulatory
- QMS Audit assistance and Bench testing
- Manufacturing facility design
- Grant application assistance (BIRAC, PRIP, ELEVATE)
- Investor connections
Prototyping & Technology
Advanced technology development and compliance testing for innovative medical devices and diagnostics solutions.
- Wearable & IoMT development
- Point of Care diagnostics
- Remote patient monitoring
- EMI/EMC compliance testing
- Cybersecurity testing
Quality & Clinical Consulting
Expert guidance on quality management systems, certifications, and clinical study execution for regulatory compliance.
- ISO Certifications (13485, 27001, 9001, 15189, 17025)
- MDSAP, QMSR, NABH, NABL accreditations
- Clinical protocol development
- IEC approval and CTRI registration
- Health Technology Assessment
Regulatory, Licenses & Registrations
Global regulatory strategy and approval support for medical devices, biologics, and in-vitro diagnostics across major markets.
- India: CDSCO Licenses (Manufacturing, Import, Test)
- USA: USFDA (510k, IDE, Denovo)
- Europe: CE Certification (EU MDR & IVDR)
- Predicate analysis & Gap assessment
- Technical Documentation (DMF, PMF, CER)
FAST-TRACK YOUR INNOVATION IN
BIOLOGICS, MEDICAL DEVICES, DIAGNOSTICS & DIGITAL HEALTH
Expertise Across Global Compliance Frameworks
Ready to Accelerate Your Product Journey?
Partner with us across the entire product development and commercialization lifecycle from prototype to market entry and beyond.